UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000002007
Receipt number R000002444
Scientific Title A phase 2 multicenter study evaluating the safety and efficacy of Nilotinib in patients with Imatinib-resistant/intolerant Ph+CML in chronic phase
Date of disclosure of the study information 2009/06/01
Last modified on 2014/06/04 18:09:09

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Basic information

Public title

A phase 2 multicenter study evaluating the safety and efficacy of Nilotinib in patients with Imatinib-resistant/intolerant Ph+CML in chronic phase

Acronym

Multicenter study of Nilotinib in CML patients with Imatinib resistance or intolerance (Shimousa Nilotinib Study)

Scientific Title

A phase 2 multicenter study evaluating the safety and efficacy of Nilotinib in patients with Imatinib-resistant/intolerant Ph+CML in chronic phase

Scientific Title:Acronym

Multicenter study of Nilotinib in CML patients with Imatinib resistance or intolerance (Shimousa Nilotinib Study)

Region

Japan


Condition

Condition

Chronic myelogenous leukemia

Classification by specialty

Hematology and clinical oncology

Classification by malignancy

Malignancy

Genomic information

YES


Objectives

Narrative objectives1

To evaluate the efficacy and safety of Nilotinib in patients with imatinib-resistant or intolerant Ph+CML-CP.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2


Developmental phase

Phase II


Assessment

Primary outcomes

To assess the rate of major molecular response at 12 months of nilotinib therapy.

Key secondary outcomes

1) To evaluate the response rates at 12 and 24 months of nilotinib therapy.
2) To evaluate the safety of nilotinib
3) To assess the progression-free survival (PFS), the event-free survival (EFS), and the overall survival (OS) at 3 years.


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Nilotinib will be administered twice daily at a dose of 400 mg (800 mg/day) for 2 year.

Interventions/Control_2


Interventions/Control_3


Interventions/Control_4


Interventions/Control_5


Interventions/Control_6


Interventions/Control_7


Interventions/Control_8


Interventions/Control_9


Interventions/Control_10



Eligibility

Age-lower limit

16 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

1) Patients with cytogenetically confirmed newly diagnosed Ph+CML-CP.
2) CML-CP patients who have been treated with Imatinib for 3 months or longer and diagnosed with Imatinib resistance or intolerance.
3) ECOG performance status of 0-2.
4) Patients who have not experienced a blast phase or accelerated phase of CML before treatment with Nilotinib.
5) Adequate organ function.
6) Patients who are able to attend the study institution in accordance with the designated follow-up visit schedule.
7) Written informed consent prior to any study procedures being performed.

Key exclusion criteria

1) Patients who have been treated with tyrosine kinase inhibitors (except for imatinib) prior to study entry.
2) Patients whose clone exhibit the T315I BCR-ABL mutation.
3) Patients who have any cardiac disturbances.
4) Patients who are: (a) pregnant, (b) breast feeding, (c) male or female of childbearing potential unwilling to use contraceptive precautions throughout the trial.
5) Severe medical conditions.
6) Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of study drug.

Target sample size

40


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Hisashi Wakita

Organization

Japanese Red Cross Society Narita Hospital

Division name

Hematology & Oncology

Zip code


Address

90-1 Iidacho Narita, Chiba, 286-8523 Japan

TEL

0476-22-2311

Email

wakita@naritasekijyuji.jp


Public contact

Name of contact person

1st name
Middle name
Last name Kuniaki Itoh

Organization

National Cancer Center Hospital East

Division name

Division of Oncology/Hematology

Zip code


Address

6-5-1 Kashiwanoha Kashiwa, Chiba, 277-8577 Japan

TEL

04-7133-1111

Homepage URL


Email

kaito@east.ncc.go.jp


Sponsor or person

Institute

Shimousa Hematology Study Group

Institute

Department

Personal name



Funding Source

Organization

Ibaraki Hematology, Oncology & Palliation Expert Meeting(IB-HOPE)

Organization

Division

Category of Funding Organization

Non profit foundation

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



Secondary IDs

Secondary IDs

NO

Study ID_1


Org. issuing International ID_1


Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions



Other administrative information

Date of disclosure of the study information

2009 Year 06 Month 01 Day


Related information

URL releasing protocol


Publication of results

Unpublished


Result

URL related to results and publications


Number of participants that the trial has enrolled


Results


Results date posted


Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics


Participant flow


Adverse events


Outcome measures


Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

Date of protocol fixation

2009 Year 05 Month 11 Day

Date of IRB


Anticipated trial start date

2009 Year 05 Month 01 Day

Last follow-up date

2014 Year 04 Month 01 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2009 Year 05 Month 26 Day

Last modified on

2014 Year 06 Month 04 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002444


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name